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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04252846




Registration number
NCT04252846
Ethics application status
Date submitted
31/01/2020
Date registered
5/02/2020
Date last updated
8/04/2020

Titles & IDs
Public title
A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy
Scientific title
A Prospective, Non-Interventional, Observational, Multicenter Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Adjunctive Therapy in the Routine Clinical Care of Subjects >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy
Secondary ID [1] 0 0
E2007-M044-512
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Generalized Epilepsy 0 0
Partial Onset Seizures 0 0
Generalised Tonic-Clonic Seizures 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Perampanel

Perampanel - Participants with a diagnosis of epilepsy (POS with or without SG or PGTCS associated with IGE) will initiate treatment with perampanel as first adjunctive treatment as per the clinical judgment of the treating physician as part of routine clinical care. All participants will be observed prospectively for up to 12 months after initiation of perampanel treatment.


Treatment: Drugs: Perampanel
Perampanel oral tablets or oral suspension.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Retention Rate at Month 12 - Retention rate at 12 months is defined as the percentage of participants remaining on perampanel at 12 months.
Timepoint [1] 0 0
Month 12
Secondary outcome [1] 0 0
Retention Rate at Month 6 - Retention rate at 6 months is defined as the percentage of participants remaining on perampanel at 6 months.
Timepoint [1] 0 0
Month 6
Secondary outcome [2] 0 0
Pragmatic Seizure-free Rate at Months 6 and 12 - Pragmatic seizure-free rate is defined as the percentage of participants (based on all study participants) who are free of all seizures at 6 months (and for the previous 3 months) and at 12 months (and for the previous 6 months).
Timepoint [2] 0 0
Months 6 and 12
Secondary outcome [3] 0 0
Completer Seizure-free Rate at Months 6 and 12 - Completer seizure-free rate is defined as the percentage of participants (based on a subset of study participants who remain on perampanel treatment at 6 and 12 months) who are free of all seizures at 6 months (and for the previous 3 months) and at 12 months (and for the previous 6 months), respectively.
Timepoint [3] 0 0
Months 6 and 12
Secondary outcome [4] 0 0
Median Percent Change From Baseline in Seizure Frequency at Months 6 and 12 - Seizure frequency change will be measured at 6 months (averaged over the previous 3 months) and at 12 months (averaged over the previous 6 months).
Timepoint [4] 0 0
Months 6 and 12
Secondary outcome [5] 0 0
50 Percent (%) Responder Rate at Months 6 and 12 - 50% responder rate is defined as the percentage of participants with greater than or equal to (>=) 50% reduction in seizure frequency (averaged over the 3 months before the 6-month visit, and over the 6 months before the12-month visit) relative to baseline.
Timepoint [5] 0 0
Months 6 and 12
Secondary outcome [6] 0 0
Seizure Worsening Rate at Months 6 and 12 - Seizure worsening rate is defined as the percentage of participants with >=10% increase in seizure frequency (averaged over the 3 months before the 6-month visit, and over the 6 months before the 12-month visit) relative to baseline.
Timepoint [6] 0 0
Months 6 and 12
Secondary outcome [7] 0 0
Last Dose of Perampanel at Months 6 and 12
Timepoint [7] 0 0
Months 6 and 12
Secondary outcome [8] 0 0
Percentage of Participants by Perampanel Dose Titration Speed
Timepoint [8] 0 0
Up to Month 12
Secondary outcome [9] 0 0
Duration of Treatment on Perampanel
Timepoint [9] 0 0
Up to Month 12
Secondary outcome [10] 0 0
Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs),Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation, and TEAEs by Severity
Timepoint [10] 0 0
Up to Month 12

Eligibility
Key inclusion criteria
1. Diagnosis of epilepsy

2. History of POS with or without SG or PGTCS associated with IGE

3. Documented POS with or without SG or PGTCS associated with IGE, within the past 12
months

4. Previously treated with 1 or 2 AEDs as monotherapy

5. At least 4 weeks' seizure diary data, or sufficient clinical detail to calculate
baseline seizure frequency
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Episode(s) of status epilepticus within the past 6 months before Screening

2. Previously treated with 2 or more AEDs in combination (other than during
cross-titration between AED monotherapies)

3. Previous or current use of perampanel

Note: Retrospective inclusions will be allowed but only if the time between the
initiation of perampanel treatment and the inclusion does not exceed 7 calendar days

4. Hypersensitivity to perampanel or any of the excipients

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Christian-Doppler-Klinik Salzburg - Salzburg
Recruitment postcode(s) [1] 0 0
- Salzburg
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Sjælland
Country [2] 0 0
Denmark
State/province [2] 0 0
South Denmark
Country [3] 0 0
France
State/province [3] 0 0
Ille-et-Vilaine
Country [4] 0 0
France
State/province [4] 0 0
Nord
Country [5] 0 0
France
State/province [5] 0 0
Cagnes-sur-Mer
Country [6] 0 0
France
State/province [6] 0 0
Marseille
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
France
State/province [8] 0 0
Tours
Country [9] 0 0
Italy
State/province [9] 0 0
Campania
Country [10] 0 0
Italy
State/province [10] 0 0
Friuli-Venezia Giulia
Country [11] 0 0
Italy
State/province [11] 0 0
Lazio
Country [12] 0 0
Italy
State/province [12] 0 0
Lombardia
Country [13] 0 0
Italy
State/province [13] 0 0
Trentino-Alto Adige
Country [14] 0 0
Italy
State/province [14] 0 0
Bari
Country [15] 0 0
Italy
State/province [15] 0 0
Genova
Country [16] 0 0
Italy
State/province [16] 0 0
Napoli
Country [17] 0 0
Italy
State/province [17] 0 0
Roma
Country [18] 0 0
Portugal
State/province [18] 0 0
Coimbra
Country [19] 0 0
Portugal
State/province [19] 0 0
Lisboa
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Krasnoyarsk
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Moscow
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Novosibirsk
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Tyumen
Country [24] 0 0
Spain
State/province [24] 0 0
Pontevedra
Country [25] 0 0
Spain
State/province [25] 0 0
Barcelona
Country [26] 0 0
Spain
State/province [26] 0 0
Granada
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Spain
State/province [28] 0 0
Málaga
Country [29] 0 0
Spain
State/province [29] 0 0
San Sebastián
Country [30] 0 0
Spain
State/province [30] 0 0
Sevilla
Country [31] 0 0
Spain
State/province [31] 0 0
Valladolid
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Glasgow City
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Newcastle
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Newport
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Romford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eisai Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of this study is to assess the retention rate of perampanel as a reliable
proxy for overall effectiveness and tolerability in participants aged at least 12 years who
are prescribed perampanel (for partial onset seizures [POS] with or without secondary
generalization [SG] or for primary generalized tonic-clonic seizures [PGTCS] associated with
idiopathic generalized epilepsy [IGE] as first adjunctive to antiepileptic drug (AED)
monotherapy as part of their routine clinical care.
Trial website
https://clinicaltrials.gov/show/NCT04252846
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Eisai Medical Information
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
EUMedInfo@eisai.net
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04252846